Starkey Laboratories, Inc
This study is a Post-Market Clinical Investigation whose primary purpose is to evaluate hearing aid amplification and tinnitus masker performance for individuals with hearing loss and tinnitus. There are two primary hypotheses that will be assessed in this study: The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. The use of well-fit amplification in conjunction with a tinnitus masker improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions. Participants will be fit with hearing aids for 6 months and a tinnitus masker will be activated at the 3-month mark of the study. Outcome measures will evaluate device performance and participant benefit from the devices throughout the study duration.
The purpose of this study is to evaluate hearing aid amplification and tinnitus masker performance, and clinical benefit for adults with hearing loss and tinnitus. The participants of the study will include approximately 100 adults with bilateral hearing loss ranging from mild to profound and mild to severe tinnitus as determined by the Tinnitus Handicap Inventory. Participants will be fit with hearing aids by a licensed research audiologist. Hearing aid fittings will be verified using real-ear measurements and performance will be evaluated by the response accuracy compared to hearing aid pre…
Inclusion Criteria: * At least 18 years old Native English speaking (defined that all education was done in English) Bilateral hearing impairment ranging from mild to profound Mild to severe tinnitus Ability to commute to research facility Exclusion Criteria: * Participants will be advised to consult promptly a doctor, preferably an ear specialist such as an ENT, prior to being fit with the study devices, if they display any of the following conditions: Visible deformity of the ear, either congenital or traumatic Fluid, pus, or blood coming out of the ear within the previous 6 months…
Inclusion of hearing aid or not for listening
Inclusion of tinnitus masker in device
Arctuva estimate
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